FDA Adverse Event Malfunction Summary report: N

CONTAK RENEWAL

MDR report key: 1863600 · Received October 11, 2010

Report

Report Number: 2124215-2010-15381
Event Type: Malfunction
Date Received: October 11, 2010
Date of Event: July 30, 2010
Report Date: August 4, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Removal / Correction Number: Z-1192-06 THRU Z-1194-06
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR (B)(4) LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE (B)(4).

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. ANOTHER BOSTON SCIENTIFIC CRT-D WAS SUCCESSFULLY IMPLANTED. UPON RECEIPT, INITIAL ANALYSIS DETERMINED THAT THE DEVICE DID NOT MEET EXPECTED LONGEVITY PREDICTIONS AS DESCRIBED IN LABELING. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONTAK RENEWAL	IMPLANTABLE CHF GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	H177

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			N119\| 4542\| H177\| 6949\| (B)(4)